Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome

Infertility Clinical Trial

Official title:

Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702957
• Other study ID #: IRB/2015/209/SIMS
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2023
• Source: Services Institute of Medical Sciences, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.

Description:

The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019.

Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women age between 18-40 years.

• Normal husband semen analysis.

Exclusion Criteria:

• All infertile couples who had other causes of infertility than PCOS.

• Those who had recently taken these medications.

• Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug.

• BMI>35 because obese women respond poorly to ovulation induction.

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• letrozole 2.5mg-7.5mg
Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
• Clomiphene Citrate 50mg-150mg
Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.

Locations

Country	Name	City	State
Pakistan	Services Institute of Medical sciences	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Institute of Medical Sciences, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Total number of patients conceived after treatment	5th week of cycle when periods missed
Secondary	ovulation rate	when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.	10-22 day of cycle
Secondary	Live birth rate	total number of live births divided by total number of patients in a group	9 months
Secondary	Monofollicular development	when only one follicle achieve diameter of greater than or equal to 18mm	10-12 day of menstrual cycle
Secondary	Multifollicular development	when 2 or more follicles achieve diameter of >12mm	10-12 day of menstrual cycle
Secondary	Miscarraige	spontaneous loss of pregnancy before 24 weeks of gestation	Less than 24weeks
Secondary	Adverse effects	hot flushes.	first 10days of cycle
Secondary	Adverse effects	Fatigue and dizziness	first 10days of cycle